Comparison of Outcomes of Plantar vs Groin Full-Thickness Skin Graft for Correction of Congenital Syndactyly of Hand
1 other identifier
interventional
120
1 country
1
Brief Summary
Congenital syndactyly is a condition present at birth in which two or more fingers are joined together. Surgical correction was performed to separate the fingers, improve hand appearance, and support better hand function. After separation of the fingers, a skin graft is often needed to cover the skin defect created during surgery. Full-thickness skin grafts may be taken from different donor sites. The groin has commonly been used as a donor site, but groin skin may differ from hand skin in color and texture. The plantar area of the foot has been considered as an alternative donor site because it may provide better color and texture matching and the donor scar is usually less visible. This randomized controlled study compared the outcomes of plantar full-thickness skin grafts with groin full-thickness skin grafts in children who underwent surgical correction for congenital simple complete syndactyly of the hand. The study was conducted in the Department of Plastic Surgery, Sheikh Zayed Hospital, Rahim Yar Khan. Children aged 1 to 10 years with congenital simple complete syndactyly who required surgical correction with skin grafting were enrolled after written informed consent was obtained from their guardians. Children with complex syndactyly, associated congenital syndromes, infections, skin diseases, previous surgery on the affected hand, or missing postoperative photographs were not included. The participants were assigned to one of two treatment groups by sealed opaque envelopes using a lottery method. One group received a plantar full-thickness skin graft, while the other group received a groin full-thickness skin graft. All operations were performed by a consultant plastic surgeon according to standard surgical practice. Postoperative follow-up was carried out at 2 weeks, 4 weeks, and 6 weeks after surgery. The main purpose of the study was to compare postoperative complications between the two graft methods. These complications included scar contracture, web creep, donor-site hypertrophic scarring, and delayed healing. Scar contracture referred to tightening or shrinking of the graft or surrounding tissues that could limit finger movement or cause deformity. Web creep referred to distal migration of the reconstructed web space after surgery. Donor-site complications included raised or thickened scarring and delayed wound healing. These outcomes were assessed during follow-up visits by a consultant plastic surgeon who was blinded to the treatment group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFirst Submitted
Initial submission to the registry
June 10, 2026
CompletedFirst Posted
Study publicly available on registry
June 15, 2026
CompletedJune 15, 2026
June 1, 2026
10 months
June 10, 2026
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Frequency of Scar Contracture
Scar contracture was assessed as abnormal tightening or shrinkage of the graft or surrounding tissue after syndactyly correction, resulting in visible tightness, deformity, or limitation of finger movement at the surgical site. It was graded as none, mild, moderate, or severe according to clinical examination of range of motion and visible contracture. Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
2 weeks, 4 weeks, and 6 weeks after surgery
Frequency of Web Creep
Web creep was assessed as distal migration of the reconstructed web space beyond the expected anatomical location after syndactyly correction. It was evaluated by visual inspection and measurement from the metacarpophalangeal joint crease to the web apex. Web creep was categorized as absent, less than 5 mm, 5 to 10 mm, or more than 10 mm. Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
2 weeks, 4 weeks, and 6 weeks after surgery
Frequency of Donor-Site Hypertrophic Scarring
Donor-site hypertrophic scarring was assessed as a raised, thickened, erythematous, or pruritic scar confined within the boundaries of the original donor-site wound. It was evaluated through visual and tactile examination of the donor site. The outcome was recorded as present or absent. Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
2 weeks, 4 weeks, and 6 weeks after surgery
Frequency of Delayed Healing
Delayed healing was assessed as failure of complete epithelialization of the graft or donor-site wound within more than 3 weeks after surgery, or the presence of wound dehiscence, infection, necrosis, or persistent exudate. The outcome was recorded according to clinical wound examination. Assessment was performed by a consultant plastic surgeon blinded to the treatment group.
2 weeks, 4 weeks, and 6 weeks after surgery
Secondary Outcomes (3)
Aesthetic Outcome Score
6 weeks after surgery
Healing Time
Up to 6 weeks after surgery
Guardian Satisfaction Score
6 weeks after surgery
Study Arms (2)
Group I - Plantar Full-Thickness Skin Graft
EXPERIMENTALParticipants assigned to this group received surgical correction of congenital simple complete syndactyly of the hand using a plantar full-thickness skin graft. The graft was harvested from the plantar surface of the foot and used to cover the skin defect created after syndactyly release. Participants were followed postoperatively at 2 weeks, 4 weeks, and 6 weeks for assessment of healing, scar contracture, web creep, donor-site complications, guardian satisfaction, and aesthetic outcome.
Group II - Groin Full-Thickness Skin Graft
ACTIVE COMPARATORParticipants assigned to this group received surgical correction of congenital simple complete syndactyly of the hand using a groin full-thickness skin graft. The graft was harvested from the groin region and used to cover the skin defect created after syndactyly release. Participants were followed postoperatively at 2 weeks, 4 weeks, and 6 weeks for assessment of healing, scar contracture, web creep, donor-site complications, guardian satisfaction, and aesthetic outcome.
Interventions
Syndactyly release was performed under standard surgical protocol. A full-thickness skin graft was harvested from the plantar surface of the foot and applied to the recipient defect after separation of the fused fingers.
Syndactyly release was performed under standard surgical protocol. A full-thickness skin graft was harvested from the groin region and applied to the recipient defect after separation of the fused fingers.
Eligibility Criteria
You may qualify if:
- Patients aged 1 to 10 years of either gender with congenital simple complete syndactyly
- Cases requiring surgical correction with skin grafting.
- Patients with no prior surgical intervention on the affected hand.
You may not qualify if:
- Patients with complex syndactyly or other systemic conditions, including congenital syndromes, infections and skin diseases
- Patients with missing postoperative photographs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheikh Zayed Medical college/hospital
Rahim Yar Khan, Punjab Province, 64200, Pakistan
Study Officials
- PRINCIPAL INVESTIGATOR
Wardah Rehmat
Sheikh Zayed Medical college/Hospital, Rahimyar Khan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2026
First Posted
June 15, 2026
Study Start
March 1, 2025
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
June 15, 2026
Record last verified: 2026-06