SAFETY OF THE NO-FLIP TECHNIQUE AND SPONTANEOUS...
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www.engenderhealth.org SAFETY OF THE NO-FLIP TECHNIQUE AND SPONTANEOUS DETACHMENT FOR SHANGRING CIRCUMCISION IN BOYS AND MEN: RESULTS FROM A RANDOMIZED CONTROLLED TRIAL Awori Q 1 , Lee R 2 , Li P 2 , Ouma D 1 , Obura N 1 , Oundo M 1 , Mwamkita D 1 , Chirchir B 3 , Barasa M 3 , Kirui M 3 , Macharia P 3,4 , Oketch J 5 , Otiende P 5 , Nyangweso N 5 , Maina M 6 , Kiswi N 6 , Goldstein M 2 , Nyanchoka J 1 , Barone MA 1 STUDY LOCATION Men and boys seeking VMMC were enrolled at two sites in Kenya: Homa Bay County Referral Hospital and Vipingo Health Center in Kilifi County region SHANGRING PROCEDURE: NO-FLIP CIRCUMCISION SHANGRING PROCEDURE: RING REMOVAL BACKGROUND • Clinical data demonstrate the advantages of using devices for voluntary medical male circumcision (VMMC) in HIV prevention programs in Africa. • The ShangRing, a disposable single-use circumcision device, is simple to use, safe, and well-accepted in males ages 13 and older. It has received World Health Organization (WHO) prequalification for use in this age-group. • New clinical studies from China suggest that the innovative “no- flip” technique can simplify the ShangRing circumcision procedure. With this technique, there is no need to evert the foreskin or to make small slits on the edge of the foreskin, as is required with the original ShangRing technique. In the no-flip technique, the inner ring is placed on the inside of the foreskin and then the outer ring is placed over the inner ring, sandwiching the foreskin between the rings. • Another innovation that has the potential to simplify VMMC service delivery is the ring’s being able to fall off on its own—known as spontaneous detachment, thus eliminating the need for a removal visit. A pilot study in Kenya suggests that spontaneous detachment is safe and is acceptable to many men. OBJECTIVES PRIMARY OBJECTIVE • Assess the safety of the no-flip ShangRing technique in males aged 10 years and older SECONDARY OBJECTIVES • Assess the ease of use of the no-flip technique • Evaluate satisfaction with the no-flip technique among study participants and providers • Determine the occurrence and safety of spontaneous detachment • Evaluate the acceptability of wearing the ShangRing beyond seven days following circumcision STUDY DESIGN INTERVENTION • 230 boys and men • 115 10–15-year-olds • 115 older than 15 • Circumcision with no-flip technique • Seven circumcision providers were trained in the no-flip technique and conducted circumcisions during the study. (Two had no prior experience with the ShangRing.) FOLLOW-UP Participants were followed up at 7, 14, 21, 28, 35, and 42 days. At each follow-up, participants were evaluated on: • Degree of ring detachment • Occurrence of adverse events • Status of wound healing Participation ended when healing was documented. RANDOMIZATION Control Group Ring removal seven days after circumcision Treatment Group Observation for spontaneous detachment* *Could request removal at any time. Kenya Homa Bay Vipingo Measure the penis with special measuring tape. Place the outer ring around, then close it, clamping the foreskin. Cut the foreskin on the upper side of the device. Grasp edges of the foreskin. Insert the inner ring, using a dorsal slit where necessary. Open the outer ring… Remove the inner ring. The circumcision is complete. …then remove it. Nudge off remnant scab from the inner ring. CONCLUSIONS • The no-flip technique was safe, effective, and well-accepted by participants, irrespective of age. • The no-flip technique was preferred by providers—even by those who had previous experience with the original ShangRing technique. • There were no significant differences in safety, time to healing, and client preference between the seven- day removal and spontaneous detachment groups. • There also were no significant differences in the time to ring detachment between younger and older participants in the spontaneous detachment group. • Three out of four participants in the spontaneous detachment group wore the ring until it fell off on its own. This could have a significant impact on reducing burden of services at VMMC service delivery points. More importantly, there is no increased risk of adverse events if users do not come back for removal. • Participants who requested early removal were more likely to be older. ACKNOWLEDGMENTS This research was carried out with support from a grant from the Bill & Melinda Gates Foundation to conduct research on the ShangRing, in collaboration with EngenderHealth, Weill Cornell Medical College, and the Kenya Ministry of Health. 1 EngenderHealth; 2 Weill Cornell Medical College; 3 Bon Santé Consulting; 4 Ministry of Health, Kenya National AIDS & STIs Control Programme; 5 Homa Bay County Hospital; 6 Vipingo Health Centre Questions or Comments? Please contact: Quentin Awori Medical Associate EngenderHealth KENYA [email protected] | +254 722 913 616 OUTCOMES: CIRCUMCISIONS AND REMOVALS The males circumcised were randomized into two groups—for removal on Day 7 or for spontaneous detachment, stratified by age- group Age (yrs.) Day 7 removal Spontaneous Total 10–15 57 58 115 >15 57 58 115 Total 114 116 230 ADVERSE EVENTS,* BY RANDOMIZATION GROUP • Six moderate adverse events were reported—four infections and two cases of edema. • There were no significant differences in adverse events by randomization group. • All cases of infection were reported by newly trained providers from one site and clustered during the earlier stages of the study. • All adverse events resolved with conservative management and without sequelae. *Based on the definitions outlined by the WHO Technical Advisory Group on Innovations in Male Circumcision, adapted to be applicable to device-specific adverse events. SURGICAL OUTCOMES: NO-FLIP TECHNIQUE • All participants were successfully circumcised using the no-flip ShangRing technique. • No adverse events occurred during the circumcision procedure. • Mean circumcision time did not vary by age of participant.* *Outlier observations (beyond 1.5 interquartile range) were excluded from analysis (seven from each group). SPONTANEOUS DETACHMENT: EARLY REMOVAL The ShangRing fell off on its own without incident in three-quarters of the participants randomized to the spontaneous detachment group. The remaining one-quarter of clients requested ring removal due to pain and discomfort from the partially detached ring 1–3 weeks after circumcision. Odds of early removal by age-group: Compared with the 10–15 age-group, participants older than age 15 were 2.5 times more likely to request early ring removal. However, this observation was not statistically significant (p=.06). Circumcision procedure 10–15 (N=115) >15 (N=115) Par$cipants with phimosis requiring small dorsal slit 43 (37.4%) 17 (14.8%) Par$cipants with penile adhesions that needed to be broken down 55 (47.8%) 3 (2.6%) Mean circumcision $me (in minutes) (SD) 7.0 (2.0) 6.7 (1.9) Minor problems occurring during procedure 2 (1.7%) 2 (1.7%) 10–15 (n=58) >15 (n=58) Total (n=116) Request for early removal 10 (17.2%) 20 (34.5%) 30 (25.9%) Spontaneous detachment 48 (82.8%) 38 (65.5%) 86 (74.1%) KAPLAN-MEIER ANALYSIS OF RING DETACHMENT There was no significant difference in the probability of ring detachment between the two age-groups (log rank test: chi2=1.3 on 1 dof, p=.26). KAPLAN-MEIER ANALYSIS OF WOUND HEALING There was no significant different in time to healing between the seven-day removal and the spontaneous detachment groups (log rank test: chi2= 1.3 on 1 dof, p=.26). PARTICIPANT SATISFACTION, BY RANDOMIZATION GROUP Between the two groups, there were no significant differences in interference with daily activities, satisfaction with appearance, or likelihood of recommendation of procedure to others. PROVIDER PREFERENCE FOR CONVENTIONAL SHANGRING VS. NO-FLIP TECHNIQUE All five providers who had experience with both the original ShangRing technique and the no-flip technique strongly preferred the no-flip technique, due to its ease of circumcision. They further observed that one adverse event associated with the original ShangRing (the “cutaneous pinch”) was not a problem with the no-flip technique. 0.0 0 5 10 15 20 25 10-15 > 15 30 35 0.2 0.4 0.6 0.8 0.10 Probability of ring detachment No. of days following circumcision 0.0 0 10 20 30 40 Day 7 Spontaneous 50 60 0.2 0.4 0.6 0.8 0.10 Probability of healing No. of days post circumcision Day 7 (N=114) Spontaneous (N=116) p value (å=.05) Interference while wearing the ring during the first week, mean (SD) (Scale 0-10; lower is beKer) – Walking – Sleeping – Working 0.27 (0.71) 0.41 (1.02) 0.59 (0.96) 0.44 (1.09) 0.42 (1.07) 0.57 (1.37) .168 .937 .898 N=106 N=107 SaNsfacNon with appearance of the penis at the final visit – Very saNsfied – Somewhat saNsfied 105 (99.1%) 1 (0.9%) 103 (96.3%) 4 (3.7%) Would recommend circumcision to others 106 (100.0%) 106 (99.1%) Adverse events Day 7 (N=114) Spontaneous (N=116) Moderate Edema Infec+on 6 2 4 2 2 0 Severe 0 0 Total 6 2
Transcript of SAFETY OF THE NO-FLIP TECHNIQUE AND SPONTANEOUS...
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SAFETY OF THE NO-FLIP TECHNIQUE AND SPONTANEOUS DETACHMENT FOR SHANGRING CIRCUMCISION IN BOYS AND MEN: RESULTS FROM A RANDOMIZED CONTROLLED TRIALAwori Q1, Lee R2, Li P2, Ouma D1, Obura N1, Oundo M1, Mwamkita D1, Chirchir B3, Barasa M3, Kirui M3, Macharia P3,4, Oketch J5, Otiende P5, Nyangweso N5, Maina M6, Kiswi N6, Goldstein M2, Nyanchoka J1, Barone MA1
STUDY LOCATION
Men and boys seeking VMMC were enrolled at two sites in Kenya: Homa Bay County Referral Hospital and Vipingo Health Center in Kilifi County region
SHANGRING PROCEDURE: NO-FLIP CIRCUMCISION
SHANGRING PROCEDURE: RING REMOVAL
BACKGROUND
• Clinical data demonstrate the advantages of using devices for voluntary medical male circumcision (VMMC) in HIV prevention programs in Africa.
• The ShangRing, a disposable single-use circumcision device, is simple to use, safe, and well-accepted in males ages 13 and older. It has received World Health Organization (WHO) prequalifi cation for use in this age-group.
• New clinical studies from China suggest that the innovative “no-fl ip” technique can simplify the ShangRing circumcision procedure. With this technique, there is no need to evert the foreskin or to make small slits on the edge of the foreskin, as is required with the original ShangRing technique. In the no-fl ip technique, the inner ring is placed on the inside of the foreskin and then the outer ring is placed over the inner ring, sandwiching the foreskin between the rings.
• Another innovation that has the potential to simplify VMMC service delivery is the ring’s being able to fall off on its own—known as spontaneous detachment, thus eliminating the need for a removal visit. A pilot study in Kenya suggests that spontaneous detachment is safe and is acceptable to many men.
OBJECTIVES
PRIMARY OBJECTIVE• Assess the safety of the no-fl ip ShangRing technique in
males aged 10 years and older
SECONDARY OBJECTIVES• Assess the ease of use of the no-fl ip technique • Evaluate satisfaction with the no-fl ip technique among
study participants and providers• Determine the occurrence and safety of spontaneous
detachment• Evaluate the acceptability of wearing the ShangRing
beyond seven days following circumcision
STUDY DESIGN
INTERVENTION• 230 boys and men
• 115 10–15-year-olds• 115 older than 15
• Circumcision with no-fl ip technique
• Seven circumcision providers were trained in the no-fl ip technique and conducted circumcisions during the study. (Two had no prior experience with the ShangRing.)
FOLLOW-UP
Participants were followed up at 7, 14, 21, 28, 35, and 42 days.At each follow-up, participants were evaluated on:• Degree of ring detachment• Occurrence of adverse
events • Status of wound healingParticipation ended when healing was documented.
RANDOMIZATION
Control Group
Ring removal seven days after circumcision
Treatment Group
Observation for spontaneous detachment**Could request removal at any time.
Kenya
Homa Bay Vipingo
Measure the penis with special measuring tape.
Place the outer ring around, then close it, clamping the foreskin.
Cut the foreskin on the upper side of the device.
Grasp edges of the foreskin.
Insert the inner ring, using a dorsal slit where necessary.
Open the outer ring…
Remove the inner ring.
The circumcision is complete.
…then remove it. Nudge off remnant scab from the inner ring.
CONCLUSIONS
• The no-fl ip technique was safe, effective, and well-accepted by participants, irrespective of age.• The no-fl ip technique was preferred by providers—even by those who had previous experience with the
original ShangRing technique.• There were no signifi cant differences in safety, time to healing, and client preference between the seven-
day removal and spontaneous detachment groups.
• There also were no signifi cant differences in the time to ring detachment between younger and older participants in the spontaneous detachment group.
• Three out of four participants in the spontaneous detachment group wore the ring until it fell off on its own. This could have a signifi cant impact on reducing burden of services at VMMC service delivery points. More importantly, there is no increased risk of adverse events if users do not come back for removal.
• Participants who requested early removal were more likely to be older.
ACKNOWLEDGMENTS This research was carried out with support from a grant from the Bill & Melinda Gates Foundation to conduct research on the ShangRing, in collaboration with EngenderHealth, Weill Cornell Medical College, and the Kenya Ministry of Health.
1EngenderHealth; 2Weill Cornell Medical College; 3Bon Santé Consulting; 4Ministry of Health, Kenya National AIDS & STIs Control Programme; 5Homa Bay County Hospital; 6Vipingo Health Centre
Questions or Comments?Please contact:Quentin AworiMedical [email protected] | +254 722 913 616
OUTCOMES: CIRCUMCISIONS AND REMOVALS
The males circumcised were randomized into two groups—for removal on Day 7 or for spontaneous detachment, stratifi ed by age-group
Age(yrs.) Day7removal Spontaneous Total
10–15 57 58 115>15 57 58 115Total 114 116 230
ADVERSE EVENTS,* BY RANDOMIZATION GROUP
• Six moderate adverse events were reported—four infections and two cases of edema.• There were no signifi cant differences in adverse events by randomization group.• All cases of infection were reported by newly trained providers from one site and clustered during the
earlier stages of the study.
• All adverse events resolved with conservative management and without sequelae.
*Based on the defi nitions outlined by the WHO Technical Advisory Group on Innovations in Male Circumcision, adapted to be applicable to device-specifi c adverse events.
SURGICAL OUTCOMES: NO-FLIP TECHNIQUE
• All participants were successfully circumcised using the no-fl ip ShangRing technique.• No adverse events occurred during the circumcision procedure. • Mean circumcision time
did not vary by age of participant.*
*Outlier observations (beyond 1.5 interquartile range) were excluded from analysis (seven from each group).
SPONTANEOUS DETACHMENT: EARLY REMOVAL
The ShangRing fell off on its own without incident in three-quarters of the participants randomized to the spontaneous detachment group. The remaining one-quarter of clients requested ring removal due to pain and discomfort from the partially detached ring 1–3 weeks after circumcision.
Odds of early removal by age-group:Compared with the 10–15 age-group, participants older than age 15 were 2.5 times more likely to request early ring removal. However, this observation was not statistically signifi cant (p=.06).
Circumcisionprocedure 10–15(N=115)
>15(N=115)
Par$cipantswithphimosisrequiringsmalldorsalslit 43(37.4%) 17(14.8%)
Par$cipantswithpenileadhesionsthatneededtobebrokendown
55(47.8%) 3(2.6%)
Meancircumcision$me(inminutes)(SD) 7.0(2.0) 6.7(1.9)
Minorproblemsoccurringduringprocedure 2(1.7%) 2(1.7%)
10–15(n=58) >15(n=58) Total(n=116)
Requestforearlyremoval
10(17.2%) 20(34.5%) 30(25.9%)
Spontaneousdetachment 48(82.8%) 38(65.5%) 86(74.1%)
KAPLAN-MEIER ANALYSIS OF RING DETACHMENT
There was no signifi cant difference in the probability of ring detachment between the two age-groups (log rank test: chi2=1.3 on 1 dof, p=.26).
KAPLAN-MEIER ANALYSIS OF WOUND HEALING
There was no signifi cant different in time to healing between the seven-day removal and the spontaneous detachment groups (log rank test: chi2= 1.3 on 1 dof, p=.26).
PARTICIPANT SATISFACTION, BY RANDOMIZATION GROUP
Between the two groups, there were no signifi cant differences in interference with daily activities, satisfaction with appearance, or likelihood of recommendation of procedure to others.
PROVIDER PREFERENCE FOR CONVENTIONAL SHANGRING VS. NO-FLIP TECHNIQUE
All fi ve providers who had experience with both the original ShangRing technique and the no-fl ip technique strongly preferred the no-fl ip technique, due to its ease of circumcision. They further observed that one adverse event associated with the original ShangRing (the “cutaneous pinch”) was not a problem with the no-fl ip technique.
0.0
0 5 10 15 20 25
10-15> 15
30 35
0.2
0.4
0.6
0.8
0.10
Prob
abili
ty o
f rin
g d
etac
hmen
t
No. of days following circumcision
0.0
0 10 20 30 40
Day 7Spontaneous
50 60
0.2
0.4
0.6
0.8
0.10
Prob
abili
ty o
f hea
ling
No. of days post circumcision
Day7(N=114)
Spontaneous(N=116)
pvalue(å=.05)
Interferencewhilewearingtheringduringthefirstweek,mean(SD)(Scale0-10;lowerisbeKer)
–Walking–Sleeping–Working
0.27(0.71)0.41(1.02)0.59(0.96)
0.44(1.09)0.42(1.07)0.57(1.37)
.168
.937
.898
N=106 N=107
SaNsfacNonwithappearanceofthepenisatthefinalvisit–VerysaNsfied
–SomewhatsaNsfied
105(99.1%)1(0.9%)
103(96.3%)4(3.7%)
Wouldrecommendcircumcisiontoothers 106(100.0%) 106(99.1%)
Adverseevents Day7(N=114)
Spontaneous(N=116)
ModerateEdemaInfec+on
624
220
Severe 0 0
Total 6 2
