Reduction of de novo postsurgical adhesions by intraoperative precoating with Sepracoat* (HAL-C) solution

A prospective, randomized, blinded, placebo-controlled multicenter study

Michael Peter Diamond, Kevin Bachus, Eric Bieber, Karen Bradshaw, Tommaso Falcone, Gary Frishman, George Grunert, Keith Hansen, Robert Hemmings, Rogerio Lobo, Andrew Mok, Ewa Radwanska, William Schlaff, Kaylen Silverberg, Michael Steinkampf, Thomas C. Vaughn, Craig Witz, Ellen Smith, Daniel Gehlbach

Research output: Contribution to journalArticle

145 Citations (Scopus)

Abstract

Objective: To assess the efficacy and safety of Sepracoat (HAL-C; Genzyme Corporation, Cambridge, MA) solution in reducing the incidence, severity, and extent of de novo adhesion formation at sites without direct surgical trauma or adhesiolysis at the time of gynecologic laparotomy. Design: Prospective, randomized, blinded, placebo-controlled multicenter study. Patients underwent gynecologic procedures via laparotomy; approximately 40 days later, surgeons assessed their adhesions during second- look laparoscopy. Setting: Twenty-three North American institutions. Patient(s): Two hundred seventy-seven women for safety evaluations; 245 women for efficacy studies. Intervention(s): Intraoperative serosal coating with Sepracoat (treatment) or phosphate-buffered saline (placebo) after opening of the abdominal cavity, after irrigation or every 30 minutes during surgery, and at the completion of surgery. Main Outcome Measure(s): Incidence, severity, and extent of de novo adhesions to 23 intraabdominal sites. Result(s): The Sepracoat group had a significantly lower incidence of de novo adhesions than the placebo group as assessed by the proportion of sites involved (0.23 ± 0.02 versus 0.30 ± 0.02, respectively) and the percentage of patients without de novo adhesions (13.1% versus 4.6%, respectively), as well as significantly reduced adhesion extent and severity. Sepracoat was well tolerated, with a safety profile nearly identical to that of the placebo. Conclusion(s): Sepracoat was significantly more effective than placebo and was safe in reducing the incidence, extent, and severity of de novo adhesions to multiple sites indirectly traumatized by gynecologic surgery via laparotomy.

Original languageEnglish (US)
Pages (from-to)1067-1074
Number of pages8
JournalFertility and sterility
Volume69
Issue number6
DOIs
StatePublished - Jun 1 1998

Fingerprint

Multicenter Studies
Placebos
Laparotomy
Incidence
Safety
Gynecologic Surgical Procedures
Abdominal Cavity
Laparoscopy
Phosphates
Outcome Assessment (Health Care)
Seprafilm
Wounds and Injuries
Therapeutics

Keywords

  • Adhesion formation
  • Adhesions
  • De novo adhesions
  • Gynecologic surgery
  • HAL-C
  • Indirect surgical trauma
  • Postoperative adhesions
  • Sepracoat

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Reduction of de novo postsurgical adhesions by intraoperative precoating with Sepracoat* (HAL-C) solution : A prospective, randomized, blinded, placebo-controlled multicenter study. / Diamond, Michael Peter; Bachus, Kevin; Bieber, Eric; Bradshaw, Karen; Falcone, Tommaso; Frishman, Gary; Grunert, George; Hansen, Keith; Hemmings, Robert; Lobo, Rogerio; Mok, Andrew; Radwanska, Ewa; Schlaff, William; Silverberg, Kaylen; Steinkampf, Michael; Vaughn, Thomas C.; Witz, Craig; Smith, Ellen; Gehlbach, Daniel.

In: Fertility and sterility, Vol. 69, No. 6, 01.06.1998, p. 1067-1074.

Research output: Contribution to journalArticle

Diamond, MP, Bachus, K, Bieber, E, Bradshaw, K, Falcone, T, Frishman, G, Grunert, G, Hansen, K, Hemmings, R, Lobo, R, Mok, A, Radwanska, E, Schlaff, W, Silverberg, K, Steinkampf, M, Vaughn, TC, Witz, C, Smith, E & Gehlbach, D 1998, 'Reduction of de novo postsurgical adhesions by intraoperative precoating with Sepracoat* (HAL-C) solution: A prospective, randomized, blinded, placebo-controlled multicenter study', Fertility and sterility, vol. 69, no. 6, pp. 1067-1074. https://doi.org/10.1016/S0015-0282(98)00057-0
Diamond, Michael Peter ; Bachus, Kevin ; Bieber, Eric ; Bradshaw, Karen ; Falcone, Tommaso ; Frishman, Gary ; Grunert, George ; Hansen, Keith ; Hemmings, Robert ; Lobo, Rogerio ; Mok, Andrew ; Radwanska, Ewa ; Schlaff, William ; Silverberg, Kaylen ; Steinkampf, Michael ; Vaughn, Thomas C. ; Witz, Craig ; Smith, Ellen ; Gehlbach, Daniel. / Reduction of de novo postsurgical adhesions by intraoperative precoating with Sepracoat* (HAL-C) solution : A prospective, randomized, blinded, placebo-controlled multicenter study. In: Fertility and sterility. 1998 ; Vol. 69, No. 6. pp. 1067-1074.
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abstract = "Objective: To assess the efficacy and safety of Sepracoat (HAL-C; Genzyme Corporation, Cambridge, MA) solution in reducing the incidence, severity, and extent of de novo adhesion formation at sites without direct surgical trauma or adhesiolysis at the time of gynecologic laparotomy. Design: Prospective, randomized, blinded, placebo-controlled multicenter study. Patients underwent gynecologic procedures via laparotomy; approximately 40 days later, surgeons assessed their adhesions during second- look laparoscopy. Setting: Twenty-three North American institutions. Patient(s): Two hundred seventy-seven women for safety evaluations; 245 women for efficacy studies. Intervention(s): Intraoperative serosal coating with Sepracoat (treatment) or phosphate-buffered saline (placebo) after opening of the abdominal cavity, after irrigation or every 30 minutes during surgery, and at the completion of surgery. Main Outcome Measure(s): Incidence, severity, and extent of de novo adhesions to 23 intraabdominal sites. Result(s): The Sepracoat group had a significantly lower incidence of de novo adhesions than the placebo group as assessed by the proportion of sites involved (0.23 ± 0.02 versus 0.30 ± 0.02, respectively) and the percentage of patients without de novo adhesions (13.1{\%} versus 4.6{\%}, respectively), as well as significantly reduced adhesion extent and severity. Sepracoat was well tolerated, with a safety profile nearly identical to that of the placebo. Conclusion(s): Sepracoat was significantly more effective than placebo and was safe in reducing the incidence, extent, and severity of de novo adhesions to multiple sites indirectly traumatized by gynecologic surgery via laparotomy.",
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AU - Bachus, Kevin

AU - Bieber, Eric

AU - Bradshaw, Karen

AU - Falcone, Tommaso

AU - Frishman, Gary

AU - Grunert, George

AU - Hansen, Keith

AU - Hemmings, Robert

AU - Lobo, Rogerio

AU - Mok, Andrew

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AU - Schlaff, William

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